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Introducing BRCAvantageTM - Genetic testing for BRCA1 and BRCA2

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Compared to the general population, patients with a confirmed BRCA1or BRCA2 mutation are at greater risk of developing cancer during their lifetime. Women have up to an 85% risk of breast cancer and up to a 40% risk of ovarian cancer. Men also have up to a 7% risk for prostate, breast and other cancers. Their children, siblings and parents face a 50% chance of having the same autosomal dominant mutation.

Valuable genetic information can empower physicians and patients to help shape patient management.There’s a need to know if a BRCA mutation is present, because proactive steps can be taken to mitigate the risk of cancer for patient and family members both today and tomorrow.

fast, economical testing to provide answers needed for making important treatment decisions.Pre-Authorization support streamlines the process and eases the workload.

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Bordetella Pertussis / Parapertussis PCR

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As of Monday, December 15, 2014, B. pertussis / parapertussis PCR testing is performed at Mid America Clinical Laboratories’ Regional facility. This is a laboratory-developed test, using Focus Simplexa reagents on a 3M Integrated Cycler platform. This test will be performed daily, with an expected turnaround time of < 24 hours (weekends may be up to 48 hours, dependent upon time of receipt).

Test codes currently in use will remain the same. Please note that the collection device may differ, depending upon the collection medium currently in use at your facility.

Most likely, the most problematic pap interpretation is that of an Unsatisfactory interpretation.Unfortunately, even the most experienced practitioner eventually experiences an unsatisfactory result.It is important to understand the criteria used when determining adequacy and address some common concerns.We offer tips in this article to assist practitioners in lowering unsatisfactory pap rates.

Satisfactory vs. Unsatisfactory: The first check at MACL is to determine if our technical processes are at fault. We will rerun the test if necessary.Our guidance for determining adequacy comes from The Bethesda System for Reporting Cervical Cytology 2001.These guidelines state that a minimum of 5000 well-visualized/preserved squamous cells are needed for a specimen to be considered satisfactory.At MACL, we apply these standards to most adequacy assessments.However, we also recognize that strict objective criteria cannot be applied in every case.For example, if the collection is from a total hysterectomy or an atrophic patient with negative histories, we will relax our adequacy criteria.It is our requirement that every unsatisfactory case undergoes professional hierarchical review before an unsatisfactory is released. Every unsatisfactory is recorded for future reference.

How can blood interference be avoided?Blood dilutes the ThinPrep liquid and interferes with epithelial cells getting to the slide used for microscopic evaluation.Patients in menses should be rescheduled for their pap collection.On the other hand, there is little that can be done when the cervix is friable and bleeding occurs.All bloody specimens are reprocessed with a technique that lyses the red blood cells.Reprocessing delays patient results but there is some success in obtaining satisfactory specimens.

How can mucus and inflammation be avoided? Mucus and inflammation are combined because they are often co-contributors. When we report inflammation, we are usually seeing a marked presence of acute inflammatory cells. These are usually trapped in mucus. Wiping the surface of the cervix with a swab can be used to remove excess mucus.

What can I do about issues related to lubricants? Warm water on the speculum is recommended rather than lubricant. If you do use lubricant, use it sparingly to avoid smearing on the area being sampled and use one of these four recommended brands: Surgilube, Astroglide, Crystelle, or Aseptic Control Lubricant.

How should I advise patients about personal lubricant use? According to one study, you should advise patients to avoid use of lubricants and some vaginal medications for 72+ hours prior to their scheduled pap test (http://www.jabfm.org/content/24/2/181.long 10.3122/jabfm.2011.02.100086 J Am Board Fam Med March-April 2011 vol. 24 no. 2 181-186).For example, hypersomatic lubricants such as KY Warming Liquid can irritate the epithelium and promote increased mucus production which, in turn, can interfere with the pap test.Bioadhesive polymers such as carbomers and carbopol polymers (eg, Replens lubricant and Monistat creams) may also interfere.Replens is a commonly used lubricant among postmenopausal women and advertised to last up to three days.Studies show that as little as 20 uL in the ThinPrep vial can lead to unsatisfactory results.Monistat 1 contains bioadhesives and only needs to be applied every seven days.

Can you explain how lubricants and certain vaginal medications affect the pap test?This has everything to do with the way the ThinPrep test is processed. ThinPrep specimen processing uses a semipermeable membrane filter to transfer cells to a slide.However, some lubricants and medications present in specimens may clog filters.The instrument cannot differentiate cells from lubricant and medications.It responds to the quantity of material it detects on the filter and automatically transfers the filtrate when it reaches a set threshold.This results in a decreased number of cells being transferred to the slide and inadequate cellularity may result in an ‘Unsatisfactory for Evaluation’ result.

What collection technique yields the optimal specimen?Use a cytobrush and spatula combination. Insert the brush into the cervix until only the bottom fibers are visible. Slowly rotate ¼ to ½ turn in one direction. Do NOT over-rotate as this may cause bleeding. Vigorously twirl the brush and spatula in the liquid at least ten times. Push the brush against the inside wall of the vial to remove any mucus. You can use the spatula to mechanically remove mucus and cells from the cytobrush.

How should I follow up on an unsatisfactory Pap? ASCCP and ACOG guidelines recommend repeatingthe Pap in 2 - 4 months. Treat for infectious organisms identified before repeating the Pap. If a second unsatisfactory is reported, refer the patient for colposcopy1.

Will MACL bill for the unsatisfactory?We charge for an unsatisfactory pap to recover the cost of the labor and reagents used to determine the unsatisfactory result.

If considering a diagnosis of Ebola Virus Disease (Ebola Hemorrhagic Fever or EVD), consult the Centers for Disease Control and Prevention (CDC) EVD criteria to assess your patient for consistent symptoms and relevant risk factors. Contact the Indiana State Department of Health (ISDH) for consultation and further instructions. ISDH contacts for EVD include:

Because Ebola virus infection has public health significance, patients with known or suspected EVD should not be referred to MACL Patient Care Centers or In-Office Phlebotomists. MACL does not collect or process specimens from patients suspected of having EVD. MACL does not perform testing to rule out EVD. Do not submit specimens to MACL for other testing, such as malaria, CBC, or CMET, from patients suspected for EVD until EVD has been ruled out by testing performed by the public health laboratories. Follow ISDH instructions for how to proceed with diagnostic testing.

Thank you for choosing Mid America Clinical Laboratories (MACL) for your laboratory needs.We are happy to meet your supply needs and have some helpful hints to minimize waste and increase patient satisfaction:

The most accurate and fastest way to order supplies is through our website, www.maclonline.com.On the home page, simply go to the quick links on the left side of the screen and click on Order Supplies.Enter your client number (i.e., N12345) and our system will auto populate your client information.

In the comment section, please put your name and direct dial number.We can then contact you directly to ensure accuracy and timeliness if there are any questions.

The comment section is also where you may put any detailed description of supplies that are not listed on the order form.Once your order is delivered, the inventory number will be listed and can be retained for future reference.

Monitoring usage and rotating inventory will minimize waste and may reduce the number of orders that need to be placed.

The supplies department is open Monday-Friday from 8:00 a.m. – 4:30 p.m.If you need to reach us by phone, please call 317-803-0236.If we are filling orders and unable to answer the call, please leave a message.Remember to include your name, call back number and account number.We will return the call within one business day.

Please keep a copy of the completed order form to make ordering easier the next time and ensure you’re getting the exact product you need.

Extreme weather can adversely affect specimen quality. If you use an outdoor lockbox, pay close attention to weather conditions and how they might affect your specimens awaiting pickup. Unspun or whole blood specimens may hemolyze when exposed to below freezing conditions—temperatures at or below 32° F.

Temperature extremes can impact your patients’ specimens. If not properly protected, these specimens may lead to treatment decisions based on misleading laboratory results. If your specimens will be exposed to freezing weather conditions, work with your sales representative to find the best way to protect your specimens.

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Welcome New Clients

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HRHS Community OB/Gyn Center

Mid America Clinical Laboratories would like to welcome HRHS Community OB/Gyn Center in Kokomo. Specializing in Obstetrics and Gynecology, this practice includes three physicians and one nurse practitioner. The physicians in the practice are Robert Kinsey, M.D., Cecelia Powless, M.D., Aduke Simpson, M.D., and nurse practitioner, Jennifer Hansen.

MACL looks forward to working with the physicians, nurse practitioner and the entire staff of HRHS Community OB/Gyn Center.

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MACL Reminders and Updates

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CARE360 UPDATES

Release 15.5

The following enhancements are now available in Care360 Labs & Meds

System Requirements

Additional software is now supported, including the following:

Mozilla® Firefox® 31.0 for Windows

Mac OS X 10.9 (Mavericks)

Apple® Safari® 7.0 for Mac

Clinical Messaging

When viewing a clinical message in your Inbox or Deleted Messages, you can now see the To: line, along with all recipients.

When viewing a Direct message sent from a patient using MyQuest, you can now see if the message was sent by a caregiver or parent/guardian.

Clinical Faxing

When faxing, two new message statuses are available for failed faxes:

Human Answered the Phone

Blocked Number

Managing Users

Users who have administrator permissions to manage other users now have the option of assigning users to multiple organizations.

Lab Results

When viewing results in the New Lab Results list, any filtering criteria that you specify now persists as long as you remain logged into your Care360 Labs & Meds session or until you either change the filter, clear the filter, or apply the default filter.

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Pediatric HIV Testing

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In March 2014, MidAmerica Clinical Laboratories adopted the CDC recommended HIV testing algorithm guidelines.Members of the Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children recently reviewed the guidelines for Pediatric HIV Infection.The panel suggests that HIV infection can be definitively diagnosed through use of virologic assays in most non-breastfed HIV-exposed infants by age 1 month and in virtually all infected infants by age 4 months.Tests for antibodies to HIV, do not establish the presence of HIV infection in infants due to transplacental transfer of maternal antibodies to HIV; therefore a virologic test should be used.1,2 Positive virologic tests (i.e., nucleic acid amplification tests[NAT]) indicate likely HIV infection.The initial positive biologic test results should be confirmed as soon as possible by a repeat virologic test on a second specimen because false-positive results can occur with both RNA and DNA assays.

The new testing algorithm put in place at MACL begins with a “fourth-generation” combination immunoassay that detects both HIV p24 antigen and HIV antibodies.The manufacturer has established performance for individuals younger than 2 years.Nearly all infants born to HIV-infected mothers passively acquire maternal antibody and, in some cases, will test antibody positive until age 18 months regardless of whether they are infected.Definitive diagnosis of HIV infection in early infancy requires other assays including HIV nucleic acid tests or viral culture.3

MACL will test all patient samples regardless of the patient’s age.The test’s limitations expressed by the manufacturer are included with the results.

In light of the new real-world cardiovascular outcomes data, MACL now has a new simplified report for LDL-P by NMR. This new test will only report out LDL-P. LDL-P by NMR. Test Codes for LDL-P by NMR:MACL Code (51515), Epic Code (LAB6179).

Real-world data demonstrates CVD risk reduction when

managing patients with the NMR LipoProfile test (LDL-P)

We would like to take this opportunity to share with you news regarding the latest real-world cardiovascular outcomes data entitled “Cardiovascular Risk in Patients Achieving Low-Density Lipoprotein Cholesterol and Particle Targets.” This data was recently published online and is available in the August issue of Atherosclerosis.

The new study adds to the growing body of evidence demonstrating that managing high-risk patients to a low LDL particle number (LDL-P) by the NMR LipoProfile test, can be a valuable cardiovascular risk management tool. Due to the wide variance in the cholesterol content of LDL particles among individuals, measurements of LDL cholesterol (LDL-C) and LDL-P frequently disagree, especially in patients with insulin resistance, type 2 diabetes, metabolic syndrome and those treated with lipid-lowering therapies. When disagreement occurs, LDL particle number is the more clinically reliable measure of LDL and associated with better treatment outcomes than LDL-C.

For a more accurate measurement of 25-Hydroxyvitamin D levels in pediatric patients (< 3 years of age), on October 23, 2014, MACL will begin using the test QuestAssureD (test code 91935) to report Vitamin D levels.

QuestAssureD is recommended for infants/toddlers < 3 years of age due to elevated levels of a vitamin D component called 3-epimer (also known as C3-epimer) in this age group.

Elevated levels of this component, if not subtracted from the final test result, can cause false elevations of vitamin D levels and could misclassify patients < 3 years of age as “sufficient” for vitamin D when their levels are insufficient or deficient.A patient that is misclassified might not receive necessary vitamin supplements.

The below reference describes the LC/MS/MS test that removes the 3-epimer from the final test results, and provides the data and rationale for use of this test in infants and toddlers < 3 years old age.

We want to congratulate three of our newer MACL facilities on attaining their first College of American Pathologists (CAP) accreditation. The St. Vincent Heart Center, and St. Vincent Clay and Randolph Hospital Laboratories received formal notice of their CAP accreditation in July. CAP accreditation is the “gold standard” for clinical laboratories. Please join us in acknowledging their efforts to achieve this benchmark of laboratory quality.

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2014 Mid America Clinical Laboratories Client Reflex Testing

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(For testing performed by MACL)*

The most recent list of reflex tests performed at MACL is provided below. This table indicates which tests may have subsequent testing performed and the conditions that trigger the reflex test order.

Effective August 15, 2014, CIGNA updated its Medical Coverage Policy regarding the diagnosis of Helicobacter pylori (H.pylori) infection or ANY other indication using serology/antibody testing (CPT code 86677*) to comply with guideline recommendations by the American College of Gastroenterology and the American Gastroenterology Association.According to the guidelines, serology testing for H. pylori is considered “experimental, investigational, and unproven.”The guidelines recommend testing for active infection using either H. pylori stool antigen or H. pylori Urea Breath Test.

H. pylori Urea Breath Test and Stool Antigen Test can both detect active infection, confirm eradication and are supported in guidelines by the American College of Gastroenterology and American Gastroenterology Association

Antibody tests cannot differentiate active infection from past infection.They can’t be used after treatment to see if the patient is cured.Also, they have a poor positive predictive value in populations with a low H. pylori prevalence and are not guideline supported to diagnose active infection

As a national contracted laboratory for CIGNA members, we offer the following guideline-supported active testing options:

H. pylori Urea Breath Test, and

H. pylori Stool Antigen Test

Both tests can be used to identify active infection and also to confirm eradication post-treatment.

For more information, please contact your MACL Sales Representative.

*The CPT codes provided are based on AMA guidelines and are for informational purposes only.CPT coding is the sole responsibility of the billing party.Please direct any questions regarding coding to the payer being billed.

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Changes in Testing Algorithm and Reporting Practices for Antinuclear Antibodies and Immunohistochemical Patterns by IFA

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Autoimmune diseases, including rheumatoid arthritis, polymyositis, Sjogren’s syndrome, systemic lupus erythematosus, systemic sclerosis, and others, are notoriously difficult to diagnose and the laboratory work-up for these patients is crucial to the process. Anti-nuclear antibodies (ANA) in particular are hallmarks of many autoimmune diseases.

Indirect immunofluorescence assay (IFA) is considered the gold standard for ANA screening by the American College of Rheumatology due to its high sensitivity. However, low specificity for the detection of rheumatic diseases and a high false positive rate are among the limitations of IFA. In an effort to compensate for these drawbacks and provide our clients with the most accurate and timely patient results, Mid America Clinical Laboratories has transitioned to a new platform for ANA Screen by IFA. The substrate will change from HEp-2000 to HEp-2 (human epithelial cell). The new technology offers significant improvement in both turnaround time and slide quality. It incorporates a more purified (Fc specific) anti-human IgG conjugate which ensures detection of only pathogenic antibodies and significantly decreases the false positivity rate of this assay.

To further aid our clients, we are expanding our testing menu to offer a more comprehensive rheumatic disease-targeted diagnostic algorithm. In addition to IFA, Mid America Clinical Laboratories will offer ANA screening by a multiplex platform – ANAChoice. This is a high-throughput multiplex bead immunoassay, which allows for a simultaneous analysis of the most clinically relevant 13 autoimmune analytes (SSA, SSB, Sm, Sm/RNP, RNP, Scl70, centromere B, dsDNA, chromatin, Jo1, and ribosomal P proteins). The ANAChoice screen will be reported as negative if autoantibodies to any of the above 13 antigens are not detected. If they are present, a cascade of reflex testing will be initiated.

Multiplex immunoassays offer a great improvement in the diagnostic power of ANA testing by providing rapid and more specific results. However, relying on a limited number of antigens can lead to false-negative results. Thus, to better facilitate our clients, we will offer the following three first-line test codes to aid in diagnosing autoimmune diseases:

Two new patterns regarding cytoplasmic fluorescence added. Cytoplasmic fluorescence will be reported if observed on the HEp-2 Slides, even in the case of negative nuclear staining. Cytoplasmic staining observed by IFA has important clinical significance as it is indicative of primary biliary cirrhosis. The following two patterns will be implemented:

1.“Cytoplasmic pattern detected, ANA positive”

2.“Cytoplasmic pattern detected, ANA negative”

Seven new subcategories will be added under an “Atypical Pattern” replacing the existing “Atypical Speckled Pattern.” Most recent published guidelines3 and vendor recommendations suggest that the clinical significance of rare patterns (other than the most commonly observed: Homogeneous, Speckled, Centromere and Nucleolar) should not be ignored. The previously available “Atypical Speckled Pattern” category did not correspond to a single particular pattern, but included many rarely seen patterns, which current publications associate with different clinical indications. Thus, this pattern is being replaced by a new umbrella “Atypical Pattern” encompassing seven new rare patterns:

Otsuka, the makers of the H. pylori Breath Test, acquired FDA approval for Pediatrics.Effective July 1, Mid America Clinical Laboratories can provide H. pylori testing to anyone over the age of 3.In children age 3-17, a weight and height MUST be provided in order to determine results.The Mid America Patient Care Centers listed below are able to determine weight and height.

Eagle Highlands PCCTerre Haute PCC

3850 Shore Drive, Suite 1014797 S. 7th Street

Indianapolis, IN46254Terre Haute, IN47802

21st & Shadeland PCCHamilton Health Center PCC

2040 N. Shadeland Ave., Suite 1209669 E. 146th Street, #175

Indianapolis, IN 46219Noblesville, IN 46060

Marion PCCClearvista North PCC

1001 North Western, Suite B8435 Clearvista Place

Marion, IN46952Indianapolis, IN46256

County Line Road PCCTownship Line Road PCC

8920 Southpointe Dr., Bld. 2, Ste. C28071 Township Line Rd., Ste. 115

Indianapolis, IN46227Indianapolis, IN46260

Crawfordsville PCCCarmel MedCheck PCC

1601 Lafayette Rd., Ste. 20011911 N. Meridian St., Ste. 165

Crawfordsville, IN 47933Carmel, IN46032

Richmons LSC

816 Dillon Drive

Richmond, IN 47374

The urea breath test (H. pylori Breath Test) method, generally considered the gold standard in adults for diagnosis of H. pylori, is recommended for use with children by NASPGAN1,2

H. pylori is a common chronic infection affecting 1 in 4 children in the United States3

Note: Myoglobin in urine is very unstable unless the pH is between 8.0 and 9.0

Reject Criteria

Received in a non-Myoglobin transport tube; Specimen received past stability; pH <8.0

Instructions

Transfer urine to the Myoglobin transport tube within one hour of collection. Freeze and ship frozen.(Transport tube, product # 170764, is available through Client Supply)

Specimen Stability

Room temperature: UnacceptableRefrigerated: 72 hoursFrozen: 7 days

Always Message

Urinary myoglobin is highly unstable unless alkalinized with Na2CO3 preservative. Even with alkalinization, myoglobin deterioration is variable and specimen dependent (approximate averages of 10% at 1day, 20% at 3 days, and 30% at 7 days.

Performing Site

Quest Diagnostics Nichols Institute, Chantilly and Valencia

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OB/Gyn News . . .

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Test Code for Panorama is 91593

The American College of Obstetricians’ and Gynecologists' Committee Opinion of December 2012, recommends non-invasive prenatal testing of cell-free DNA (cDNA) as one of the options that can be used as a primary screening tool for women at increased risk of aneuploidy, and for women with a positive first or second trimester screening test result1.Mid America Clinical Laboratories is excited to offer Panorama as a Non-Invasive Prenatal Test (NIPT) Option.Panorama (NIPT) provides a high accuracy rate for Trisomy 21, Trisomy 18, Trisomy 13, monosomy X, and Triploidy (a major cause of miscarriage) in addition to a comprehensive microdeletion screening including 22q11.2 (also known as DiGeorge syndrome).Panorama utilizes an advanced science afforded by SNPs (single nucleotide polymorphisms) to differentiate the maternal from the fetal cell-free DNA (cfDNA) to determine the genotype of the fetus.Panorama is not impacted by ethnicity and can give results in as early as 9 weeks gestation.

This test is safe and convenient, using a simple blood sample from the mother.All Mid America Clinical Laboratories’ Patient Care Centers would be happy to assist your patient.Special glass tubes are required if you draw blood in your office.This testing has a 7-10 day turn-around time.Please contact Mid America Clinical Laboratories to learn more or call your sales representative.

Effective September 29, 2014, Mid America Clinical Laboratories will be reporting the estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation along with Chronic Kidney Disease (CKD) staging interpretations. The glomerular filtration rate (GFR) is the best overall index of the level of kidney function1, 2 and eGFR reporting is recommended by the National Kidney Foundation (NKF) and by the National Institutes of Health’s National Kidney Disease Education Program (NKDEP).

Chronic kidney disease is defined as either kidney damage or GFR <60 mL/min/1.73 m2, either condition being present for at least 3 months2. Kidney damage is defined as pathologic abnormalities or markers of damage, including abnormalities in blood, urine or imaging studies1, 2.

The National Kidney Foundation Kidney Disease:Improving Global Outcomes (KDIGO) defines the stages of CKD based on the GFR:2

Proper specimen identification is a critical step to ensuring the quality of laboratory test results. Failure to label a specimen or errors in specimen identification puts patients at significant risk of misdiagnosis, improper or unnecessary treatment, as well as, delayed treatment due to the need for recollection. Additionally, patient satisfaction is negatively impacted by improper identification.

Federal regulations require that we ensure positive identification by requiring specimen containers be labeled with two unique identifiers at the time of collection. In addition to the patient’s name, other acceptable identifiers would be date of birth, medical record number, requisition number, or specimen barcode labels unique to the patient. All specimen identifiers must match information on supporting orders and other documents. Failure to include this information results in testing delays and possible specimen rejection and request for recollection.

To ensure accurate and timely results, please check the following before submitting specimens for testing:

1.Each specimen container has two unique patient IDs (eg, name, medical record number). The specimen container itself must be labeled. Submission of an unlabeled or inadequately labeled specimen with a label in the bag is not acceptable.

2.Identification on specimen(s) match information listed on the paper or electronic requisition

3.All information is legible on specimen, paper or electronic requisition and other supporting paperwork

Patient safety is our primary concern and as such we need to ensure that the correct results are being reported on the correct patient in a timely manner. Because we value your patients, we require that all specimens have two patient identifiers on each specimen container. For irreplaceable specimens received without proper identification, we may notify you of the discrepancy or may require that you acknowledge and accept the risks involved with testing poorly labeled, mislabeled and unlabeled specimens.

Pre-authorization prompts. During order entry, if pre-authorization is required for a test, you might be prompted to provide a pre-authorization code. (You can file the order without it.) If appropriate, additional pre-authorization information is printed as well.

Requisition and label printing enhancements. In legacy order entry, if requisitions were previously embedded in the order entry page for you, they now appear in a Requisition dialog box. In addition, the ActiveX® label printer control is no longer needed and has been automatically removed.

Streamlined order entry enhancements. When you retrieve an existing patient, that patient’s pending orders (if any) no longer automatically appear on the page. If the patient has pending orders, you must click Get Pending Orders to retrieve them.

Client fax number on requisitions. If a client has a fax number in the Care360 system, that number appears alongside the client’s telephone number (if any) on the requisition. The phone number is identified by (P); the fax number is identified by (F).

Reason for canceling a filed order. When you cancel a filed order via the requisition log, you are now prompted to specify the reason for doing so. This reason appears in the requisition log and on any subsequently printed requisition.

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Trichomonas Vaginalis RNA, Qualitative TMA

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Test Code:19550

Mid America Clinical Laboratories will begin offering Trichomonas vaginalis(TV) RNA testing on July 7, 2014, using the Aptima TMA platform. This test is an FDA-cleared nucleic acid amplification test (NAAT), and is the only test cleared for symptomatic and asymptomatic women 1.

Specimen types include:

·Clinician-collected endocervical samples

·Clinician-collected vaginal samples

·PreservCyt specimens in a ThinPrep vial

·Female urine

Trichomoniasis is the most common curable and under-recognized sexually-transmitted infection (STI) 1, 2. There are 3.7 million cases in the U.S. today. This number exceeds the prevalence of chlamydia and gonorrhea infections combined 1, 2. Additionally, up to 85% of women with a TV infection are asymptomatic 2. Among the risks associated with trichomoniasis are 1:

·Prenatal:

-Premature rupture of membrane

-Pre-term delivery

-Low birth weight

·Vaginitis, cervicitis, endometritis, PID

·Cervical erosion

·Cervical dysplasia

·Prolonged HPV infection

·Infertility

·Bacterial vaginosis

·Increased acquisition/transmission of HIV

·Presence of other STIs

·Increased risk of post-surgical gynecological infections

Current CDC guidelines for TV3 :

·Testing for all women with vaginal discharge

·All symptomatic pregnant women should be considered for testing and treatment regardless of pregnancy stage

·Annual screening for HIV-positive women

·Screening can be considered for women with risk factors including new sex partners, other STIs, or inconsistent condom use

Sensitivity of the Aptima Trichomonas vaginalis RNA test reaches 100%. Other tests used to detect TV, including, Affirm VPII, culture, wet mount, and pap testing, have been shown to reach sensitivity as high as only 89% (Affirm VPII